Method and system for detecting electrophysiological changes in pre-cancerous and cancerous tissue

• US 9,037,228 B2
• Filed: 08/24/2012
• Issued: 05/19/2015
• Est. Priority Date: 05/20/2002
• Status: Expired due to Fees

• Current Assignee: Epi-Sci, LLC
• Original Assignee: Epi-Sci, LLC
• Inventors: Davies, Richard J.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US13/594,012
• Publication Number:
  US 20120323135A1
• Time in Patent Office: 998 Days
• Field of Search: 600/547
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/2415 Measuring direct current [DC] or slowly varying biopotentials
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61B 5/4381 Prostate evaluation or disorder diagnosis
• CPC Class Codes: A61B 5/6806 Gloves
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Methods and systems for determining a condition of a selected region of epithelial tissue and/or an organ in a body as well as to diagnose disease, susceptibility, premalignancy or cancer and measure response to therapy, introduction of a drug and to assess the margins of a tumor or resection. The methods utilize through the tissue or organ electrical measurements with alternating current using one or more surface or internal electrodes and measuring the electrical response using one or more surface electrodes, preferably in combination with one or more electrodes in direct or indirect contact with epithelium comprising the organ or tissue under test. The methods are also useful in combination with DC measurements on the surface of the organ or tissue under test. Measurement of impedance, admittance, electropotential and dielectric properties is particularly useful, particularly as a function of frequency and position on and in the tissue or organ.

Claims

1. A method for determining a condition of a region of ductal epithelial breast tissue comprising:

(A) establishing a connection between a first electrode and the ductal epithelial tissue of a breast;

(B) placing a second electrode in contact with the surface of the breast;

(C) establishing a signal between the first and second electrodes;

(D) measuring an electrical property between the first and second electrode;

(E) applying at least one probe comprising a plurality of probe elements to organ tissue such that individual ones of the probe elements are arranged for sensing or measuring characteristics of individual localized regions of the organ tissue; and

(F) selectively applying an electrical signal to the probe elements for determining the dielectric constants of the localized regions of the organ tissue; and

(1) determining the condition of a region of ductal epithelial tissue based on the signal between the first and second electrode;

(2) detecting a possible tumor by sensing or measuring variations in the dielectric constants over a plurality of the regions comprising ductal epithelial tissue;

or both (1) and (2).

2. The method of claim 1, wherein the electrical property is impedance or admittance.

3. The method of claim 1, wherein the electrical property is a DC potential.

4. The method of claim 1, wherein the method of establishing a connection between the first electrode and the epithelial tissue is by a cannula.

5. The method of claim 4, wherein the cannula is a ductal probe.

6. The method of claim 1, wherein the method of establishing a connection between the first electrode and the epithelial tissue is by an electroconductive media.

7. The method of claim 6, wherein the electroconductive media is a physiologic saline.

8. The method of claim 6, further comprising introducing an agent into the electroconductive media.

9. The method of claim 8, wherein the agent is a hormone.

10. A method for determining the location of a tumor in a body comprising:

(A) establishing a connection between a first electrode and ductal epithelial tissue of a duct of an organ;

(B) placing a second electrode at a second location on the body;

(C) establishing a signal between the first and second electrodes;

(D) measuring an electrical property between the first and second electrodes;

(E) applying at least one probe comprising a plurality of probe elements to organ tissue such that individual ones of the probe elements are arranged for sensing or measuring characteristics of individual localized regions of the organ tissue; and

(F) selectively applying an electrical signal to the probe elements for determining the dielectric constants of the localized regions of the organ tissue; and

(1) determining the condition of the selected region of ductal epithelial tissue based on the signal between the first and second electrode;

(2) detecting a possible tumor by sensing or measuring variations in the dielectric constants over a plurality of the regions comprising ductal epithelial tissue;

or both (1) and (2).

11. The method of claim 10, wherein the second location is on the surface of the body.

12. The method of claim 10, wherein the ductal epithelial tissue is located within the breast.

13. The method of claim 10, wherein the ductal epithelial tissue is located within the prostate.